N/A
Completed N=30
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Healthy Normals
Source: ClinicalTrials.gov NCT03257189 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device — 2.0 beats per minute
Summary
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.
Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device |
2.0 | — |
| PRIMARY Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device |
5.1 | — |
| PRIMARY Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device |
1.1 | — |
| PRIMARY Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device |
1.3 | — |
| PRIMARY Accuracy of Activity Classification as Compared to Visual Annotation |
98.7 | — |
| PRIMARY Accuracy of Step Count Compared to an Observer's Manual Count |
2.4 | — |
| PRIMARY Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation |
6.8; 11.5 | — |
| PRIMARY Accuracy of Posture Classification as Compared to Visual Annotation |
92.9 | — |
| PRIMARY Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale |
83; 92 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female volunteers, at least 18 years of age at the time of screening visit;
- Fluent in English;
- The subject is willing to comply with the protocol specified evaluations;
- Subject is willing and cognitively able to sign informed consent
Exclusion Criteria
- Pregnancy;
- Positive urine drug screen
- History of active (clinically significant) skin disorders;
- History of allergic response to silicones or adhesives;
- Subjects with electronic implants of any kind (e.g. pacemaker)
- History of sleep disorders or self-reported insomnia or other sleep conditions;
- Broken, damaged or irritated skin or rashes near the sensor application sites;
- Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
- Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.
Data sourced from ClinicalTrials.gov (NCT03257189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.